NCT04420702 Diffusion Basis Spectrum Imaging of the Prostate
| NCT ID | NCT04420702 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2020-02-27 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2020-02-27 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.
Eligibility Criteria
Inclusion Criteria: * Over 18 years of age and willing and able to provide informed consent. * Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care ("early detection cohort") * Including those men with: * an elevated PSA and no prior biopsy * an elevated PSA and a negative prior biopsy * Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care ("active surveillance cohort") Exclusion Criteria: * Patients with any clinical contraindication to MRI \*Including but not limited to: * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators * Those with cochlear implants * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate) * Those who cannot lie flat for over 1 hour * Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)
Contact & Investigator
Joseph Ippolito, M.D.
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT04420702 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04420702 currently recruiting?
Yes, NCT04420702 is actively recruiting participants. Contact the research team at ippolitoj@wustl.edu for enrollment information.
Where is the NCT04420702 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT04420702 clinical trial?
NCT04420702 is sponsored by Washington University School of Medicine. The principal investigator is Joseph Ippolito, M.D. at Washington University School of Medicine. The trial plans to enroll 500 participants.
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